See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Clinical Policy: (Seebri Neohaler) Reference Number: CP.CPA.150 Effective Date: Last Review Date: Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description (Seebri Neohaler ) inhalation powder is an anticholinergic which consists of Seebri capsules and a Neohaler device. FDA approved indication Seebri Neohaler is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (), including chronic bronchitis and/or emphysema Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation that Seebri Neohaler is medically necessary when the following criteria are met: I. Initial Approval Criteria A. (must meet all): 1. Diagnosis of including chronic bronchitis and/or emphysema; 2. Dose does not exceed 2 capsules/day. Approval duration: Length of Benefit B. Other diagnoses/indications 1. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) II. Continued Therapy A. including chronic bronchitis and/or emphysema (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 2 capsules/day. Approval duration: Length of Benefit B. B. Other diagnoses/indications (must meet 1 or 2): Page 1 of 6

2 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy CP.CPA.09 or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key : Chronic obstructive pulmonary disease HPMC: Hypromellose capsules Appendix B: General Information Seebri should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Seebri has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/Maximum Dose Advair Diskus (fluticasone propionate/salmeterol) 1 oral inhalation (250 mcg/ fluticasone/50 mcg salmeterol) BID : 250 mcg/50 mcg twice daily Symbicort (budesonide/formoterol) Dry powder inhaler: 1 oral inhalation (100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg) BID Inhalation aerosol: 2 oral inhalations (45 mcg/21 mcg, 115/21, 230/21) BID 2 oral inhalations (160 mcg/4.5 mcg per inhalation) BID 2 oral inhalations (80 mcg/4.5 mcg, 160 mcg/4.5 mcg) BID : 500 mcg/50 mcg twice daily 2 inhalations (230 mcg/21 mcg) twice daily : 320 mcg/9 mcg twice daily : 2 inhalations (160 mcg/4.5 mcg) twice daily Page 2 of 6

3 Drug Dosing Regimen Dose Limit/Maximum Dose Dulera (mometasone/formoterol) Previously on medium-dose ICS: 2 oral inhalations (100 mcg/5 mcg) BID : 400 mcg/20 mcg daily Atrovent TM HFA and 0.02% Solution for Inhalation (ipratropium bromide) Spiriva (tiotropium bromide) Tudorza TM Pressair TM (aclidinium bromide) Serevent Diskus (salmeterol xinafoate) Foradil Aerolizer, Perforomist (formoterol fumarate) Combivent Respimat and Duoneb Inhalation Solution (albuterol sulfate/ ipratropium bromide) Previously on high-dose ICS: 2 oral inhalations (200 mcg/5 mcg) BID HFA: 2 puffs (36 mcg) 4 times per day Solution for inhalation: the usual dose is 500 mcg (1 unit dose vial) administered TID to QID by nebulization, with doses 6 to 8 hours apart. Inhale the contents of 1 capsule (18 mcg) QD via Handihaler. Inhale 1 puff (400 mcg) BID 1 inhalation (50 mcg) BID, approximately 12 hours apart 1 oral inhalation (50mcg) BID Foradil: Inhale the contents of one 12 mcg capsule Q12H using the Aerolizer inhaler. Perforomist: Inhale 20 mcg BID via nebulizer Combivent Respimat: 1 inhalation QID Duoneb: one 3 ml vial (0.5 mg ipratropium bromide and 3 mg albuterol sulfate) administered QID via nebulization. 800 mcg/20 mcg daily HFA: 3 puffs 4 times per day 1 capsule per day 1 puff twice daily : 1 inhalation (50 mcg) twice daily : 1 inhalation (50mcg) twice daily Foradil: 1 capsule every 12 hours Perforomist: 40 mcg per day Combivent Respimat: 6 inhalations per day Duoneb: six 3 ml vials per day Page 3 of 6

4 Drug Dosing Regimen Dose Limit/Maximum Dose Arcapta TM Neohaler TM 75 mcg once daily (indacaterol) Inhale 75 mcg QD via a Neohaler device Brovana (arformoterol) Inhale 15 mcg (2 ml) BID via nebulizer 15 mcg twice daily Breo Ellipta (fluticasone furoate/vilanterol) 1 oral inhalation (100 mcg/25 mcg) QD 1 oral inhalation (100 mcg/25 mcg, 200 mcg/25 mcg) QD 100 mcg/25 mcg daily Incruse Ellipta (umeclidinium inhalation powder) 1 oral inhalation(62.5 mcg) QD 62.5 mcg daily Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic. V. Dosage and Administration Indication Dosing Regimen Maximum Dose 1 capsule by oral inhalation BID 2 capsules/day VI. Product Availability Inhalation powder: 15.6 mcg capsules packaged in aluminium blister cards, one Neohaler device. Unit Dose (blister pack), Box of 60 (10 blister cards with 6 orange transparent capsules each). VII. References 1. Seebri Neohaler Prescribing Information. East Hanover, NJ: Novartis; January Available at Accessed January 10, Micromedex Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 9, Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated Available at Accessed June 9, Page 4 of 6

5 Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template. Minor changes to verbiage and grammar. References updated Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. Page 5 of 6

6 This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 6 of 6